CLASS II Device recall · Reported 29 Jan 2014 · FDA Enforcement Report
ABL90 FLEX Analyzer Radiometer Medical ApS recalled
Radiometer America is recalling ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark A portable, distributed in 41 states. The recall was initiated on 15 Oct 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0816-2014
- FDA event ID
- 66875
- Recalling firm
- Radiometer America, Westlake, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Oct 2013
- FDA classified
- 23 Jan 2014
- Reported
- 29 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 15 Oct 2013 | Recall initiated by company | |
| 23 Jan 2014 | Classified by FDA | +100 days |
| 29 Jan 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results.
Product as listed by the FDA
ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
Where it was distributed
Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey & United Kingdom.
AlabamaArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIowaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesotaMissouri
Questions about this recall
Why was it recalled?
RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results.
Which lots are affected?
Lot R0375N009, Model #393-090, S/N 393-090R0027N001 - 393-090R0379N010
Where was it sold?
Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey & United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Radiometer America
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ABL90 FLEX Analyzer recalled by Radiometer America | Radiometer America | Device Malfunction | 36 states |
| Device | CLASS II | ABL800 FLEX with Crea recalled by Radiometer America | Radiometer America | Other | 31 states |
| Device | CLASS II | ABL800 analyzer recalled by Radiometer America | Radiometer America | Device Malfunction | Nationwide |
| Device | CLASS II | ABL90 FLEX analyzers recalled by Radiometer America | Radiometer America | Device Malfunction | CA |
| Device | CLASS II | ABL800 analyzer with Flexq module recalled by Radiometer America | Radiometer America | Other | Nationwide |
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